Trial of Talabostat and Gemcitabine in Patients With Stage IV Adenocarcinoma of the Pancreas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00116389
Recruitment Status : Terminated (FDA Hold May 2007)
First Posted : June 29, 2005
Last Update Posted : June 8, 2007
Information provided by:
Point Therapeutics

Brief Summary:
The purpose of this study is to assess the 6-month survival rate and safety of talabostat and gemcitabine in patients with stage IV adenocarcinoma of the pancreas.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Neoplasm Metastasis Adenocarcinoma Drug: talabostat mesylate tablets Drug: gemcitabine Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Phase 2 Trial of Talabostat and Gemcitabine in Patients With Stage IV Adenocarcinoma of the Pancreas

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 6 month survival

Secondary Outcome Measures :
  1. overall survival
  2. progression-free survival (PFS)
  3. quality of life
  4. pain
  5. performance status

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men or women age ≥18 years
  • Histologically confirmed metastatic (stage IV) adenocarcinoma of the pancreas
  • Measurable disease defined per RECIST
  • Karnofsky Performance Status ≥50
  • Expected survival ≥12 weeks
  • Provide written informed consent

Exclusion Criteria:

  • CNS metastases
  • Prior treatment with other chemotherapy for pancreatic cancer unless used as a radiosensitizer
  • Radiation therapy to >25% of the bone marrow
  • Clinically significant laboratory abnormalities
  • Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix
  • The need for chronic (i.e., >7 days) oral or intravenous corticosteroid therapy with >10mg/day prednisone equivalents
  • Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol
  • Patients who are within 28 days of radiation therapy, biologic therapy, immunotherapy, or other investigational medication. All side effects of prior treatment must have resolved at study entry.
  • Pregnancy or lactation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00116389

  Hide Study Locations
United States, Alabama
Northwest Alabama Cancer Center, PC
Florence, Alabama, United States, 35630
Northwest Alabama Cancer Center, PC
Muscle Shoals, Alabama, United States, 35661
United States, Connecticut
Oncology Associates, PC
Hartford, Connecticut, United States, 06106
United States, Florida
Palm Beach Institute of Hematology and Oncology
Boynton Beach, Florida, United States, 33435
Cancer Center of Florida
Ocoee, Florida, United States, 34761
Hematology Oncology Associates of Central Brevard
Rockledge, Florida, United States, 32955
Gulfcoast Oncology Associates
St. Petersburg, Florida, United States, 33705
United States, Illinois
Yagnesh V. Oza, MD
Mt. Vernon, Illinois, United States, 62864
United States, Indiana
Indiana Oncology Hematology Consultants
Indianapolis, Indiana, United States, 46202
Cancer Care Center, Inc.
New Albany, Indiana, United States, 47150
United States, Louisiana
Medical Oncology LLC
Baton Rouge, Louisiana, United States, 70809
United States, Michigan
Huron Medical Center
Port Huron, Michigan, United States, 48060
United States, Montana
Billings Clinic
Billings, Montana, United States, 59101
United States, New Jersey
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740
United States, New York
New York Oncology Hematology/Albany Regional Cancer Center
Albany, New York, United States, 12208
Hematology-Oncology Associates of Rockland
New City, New York, United States, 10956
United States, Ohio
Dayton Oncology and Hematology
Kettering, Ohio, United States, 45409
Lawrence M. Stallings, MD
Wooster, Ohio, United States, 44691
Trilogy Cancer Center
Wooster, Ohio, United States, 44691
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213-2933
Oregon Clinic, The
Portland, Oregon, United States, 97213
United States, South Carolina
Cancer Center of the Carolinas
Greenville, South Carolina, United States, 29615
United States, Texas
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75201
Texas Oncology, PA, Presbyterian
Dallas, Texas, United States, 75231
Baylor College of Medicine
Houston, Texas, United States, 77030
Elkins Pancreas Center
Houston, Texas, United States, 77030
Saint Luke’s Episcopal Hospital
Houston, Texas, United States, 77030
United States, Washington
Cancer Care Northwest
Spokane, Washington, United States, 99218
Sponsors and Collaborators
Point Therapeutics Identifier: NCT00116389     History of Changes
Other Study ID Numbers: PTH-320
First Posted: June 29, 2005    Key Record Dates
Last Update Posted: June 8, 2007
Last Verified: June 2007

Keywords provided by Point Therapeutics:
pancreatic cancer
cancer of the pancreas
adenocarcinoma of the pancreas
pancreatic neoplasms
Metastatic pancreatic cancer (Stage IV)
Stage IV Adenocarcinoma of the Pancreas

Additional relevant MeSH terms:
Pancreatic Neoplasms
Neoplasm Metastasis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Neoplastic Processes
Pathologic Processes
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Gastrointestinal Agents